Quality Complaint & Recall Administrator

Benefits

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Relocation assistance

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Childcare support

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Schedule

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Weekend work

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Application

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About this role

Quality Complaint & Recall Administrator Work Location (Office/Site/Home/Flexible) Office Based Quality Complaint & Recall Administrator TECHNICAL DIVISION Job title: Quality Complaint and Recall Administrator Location: Fannin House, Leopardstown, D18 Reporting to: Quality & Regulatory Lead Medical Devices Summary The Quality Complaints & Recall Administrator is responsible for the coordination and administration of complaint handling, product recalls and Field Safety Corrective Actions (FSCAs) within a regulated pharmaceutical and medical device distribution environment. The role supports compliance with GDP, GMP, MDR and IVDR requirements through effective investigation, documentation, reporting and follow-up of quality activities, while supporting Quality Management System processes and maintaining audit readiness. Principal Duties and Responsibilities: • Administration and coordination of the end-to-end complaint handling process • Coordination of product recalls and Field Safety Corrective Actions (FSCAs) • Ensure compliance with: o GDP, GMP, MDR and IVDR requirements o Vigilance and regulatory reporting requirements o Ensure complaints are assigned, investigated, and closed within defined timelines. o Escalate critical or potentially serious quality issues to the RP/QP/PRRC/Manager as appropriate. • Maintain inspection and audit readiness through accurate documentation and record management • Perform: o Complaint trending and data analysis o KPI monitoring and reporting o Training coordination for personnel on relevant quality processes • Liaise with: o Customers

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